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NCT01843933 · ClinicalTrials.gov registry record · NA
Detecting Post-Operative Respiratory Depression in Children
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 211
- Enrollment target
NCT01843933: Completed NA study, sponsored by Yale University.
NCT01843933 is a NA study that has completed, run by Yale University. The registered enrollment target is 211 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01843933, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 211 participants
- Enrollment target
Study Summary
Background: Due to the lingering effects of general anesthesia and the administration of medications for pain after surgery, children in the recovery room are at risk for breathing problems. While there are less data specific to children, in general 25% of patients in the recovery room experience complications from anesthesia. The most common complications involve the patient's airway and their ability to breath adequately. Currently, checks of oxygenation with a pulse oximetry monitor and of respiration through nursing assessments are used to detect breathing problems. However, these are believed not to be adequate for reliably recognizing significant respiratory depression until other dangerous events develop such as the cessation of breathing, severe drops in oxygen levels, or cardiac arrest. Capnography is a monitoring device that measures the amount of carbon dioxide being exhaled and assesses the adequacy of respiration. A small plastic cannula sits at the base of the nose and on the lip to continuously monitor the patient's breathing. Most children tolerate this device well and staff consider it easy to use. While capnography is routinely used in the operating room to monitor breathing, it is not used during post-operative care when patients are still at risk of breathing problems. Objectives: To determine if capnography can detect problems with breathing faster and more often than traditional monitors. To determine if the addition of capnography to routine monitoring will decrease the numbers of additional adverse events that occur in children undergoing post-operative care by allowing nurses to intervene in care faster and more frequently. Methods: In the first phase of this study, the investigators will apply the capnography monitor to children in the recover room and determine how often they experience breathing difficulties measured by this device. In the second phase, the investigators will educate staff on the use of capnography and what values are c
Primary Outcome
Mild Events/Interventions: * Mild oxygen desaturation: Pulse oximetry \< 93% on room air or \<95% on oxygen * Hypopneic hypoventilation: ETCO2 values \< 30mmHg for \>30 seconds * Bradypneic hypoventilation: ETCO2 values \> 50mmHg for \>30 seconds * Stimulation: Verbally or physical stimulation to encourage breathing Moderate Events/Interventions: * Moderate oxygen desaturation: Pulse oximetry \< 85% on room air or \<90% on oxygen * Apnea: ETCO2 value of 0mmHg or respiratory rate of 0 for \>20
Interventions
- DEVICE Capnography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-12 |
| Phase | NA |
What the finished NCT01843933 record still lists
NCT01843933 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Capnography is the first listed.
NCT01843933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01843933 about?
NCT01843933 is a clinical study titled "Detecting Post-Operative Respiratory Depression in Children". Background: Due to the lingering effects of general anesthesia and the administration of medications for pain after surgery, children in the recovery room are at risk for breathing problems. While there are less data specific to children, in general 25% of patients in the recovery room experience co...
What is the current status of trial NCT01843933?
This trial is currently completed. It is a NA study. The enrollment target is 211 participants. The study started on 2013-06. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01843933?
The interventions under investigation include: Capnography (DEVICE).
Who is sponsoring clinical trial NCT01843933?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01843933's enrollment target sits among peer trials
211 490th of 2000 higher than 1,511 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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